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AstraZeneca and Daiichi Sankyo first entered into an agreement to develop Enhertu in March 2019, and the antibody-drug conjugate has since been approved for various groups in more than 65 countries.

AstraZeneca Monotherapy for Gastric Cancer Gains Third Approval in China

The epinephrine nasal spray was approved for the emergency treatment of type 1 allergic reactions in adults and children.

First Nasal Spray for Anaphylaxis Approved by FDA

The 94.3% efficacy of the Octapharma product was just a shade ahead of the 94.2% measured in a comparative product, Kcentra.

Phase III Results Show Balfaxar Non-Inferior to Kcentra in Reversing Warfarin Therapy

The virus, which is contagious and a common cause of respiratory illness, hospitalizes up to 160,000 people and is responsible for as many as 13,000 deaths in the United States every year.

RSV Vaccine Shows Positive Results in Substudy of Phase III Trial of Immunocompromised Patients

Feliza Mirasol is the science editor for 

With the agreement, Andelyin Biosciences will add MyoAAV plasmids developed by Broad Institute of MIT and Harvard to its AAV Curator Platform.

Andelyn Biosciences and Broad Institute of MIT Enter into License Agreement to include MyoAAV Plasmids in AAV Platform

AGX101 targets the cancer cells and vasculature of a tumor, and works to eliminate the tumor blood vessels, kill tumor cells capable of invasion or metastasis, and direct the immune system to attack the cancer.

Abzena, Angiex Collaborate for Phase I Trial of Solid Cancer Tumor Therapy

The program, for which visits will be scheduled through September 2025, does not replace or supplement a regulatory inspection.

Drug Companies Encouraged by FDA to Participate in FY 2025 Site Visitation Program

 US Specialty Formulations plans to invest $15 million to expand biopharma operations at its Allentown, Pa.,facility.

US Specialty Formulations to Modernize Biopharma Operations with $15 Million Investment

The reopening of comments addresses the addition of a warning to consumers that acetaminophen may cause skin irritation characterized by reddening, blisters, and rashes.

FDA Order on OTC Monograph Drugs Containing Acetaminophen Gets Renewed Comment Period

BioIVT opened new cleanroom manufacturing space, using Germfree’s technology to boost its capabilities for cell and gene therapy development.

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